Colchicine side effects: what 26,169 FDA adverse event reports show
Drug class
Alkaloid
Who reports
26,169 reports · 81% serious · 3,239 with death outcome · 43% female
Used for
Colchicine tablets are an alkaloid indicated for: • Prophylaxis and treatment of gout flares in adults ( 1.1 ). • Familial Mediterranean fever (FMF) in adults and children 4 years or older ( Error! Hyperlink reference not valid. ). 1.1 Gout Flares Colchicine tablets are indicated for prophylaxis and the treatment of acute gout flares.
What it is
Colchicine is an alkaloid chemically described as (S)N-(5,6,7,9-tetrahydro-1,2,3,10-tetramethoxy-9-oxobenzo [alpha] heptalen-7-yl) acetamide with a molecular formula of C 22 H 25 NO 6 and a molecular weight of 399.4.
Boxed warning
None in the current label
Causality screen of the 40 strongest signals
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,175 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| X-linked lymphoproliferative syndrome | 24 | 2,104.8 978.5–4,527.8ROR 2,106.8 · calibrated p 6e-17 ✓ | 393.8 EB05 278.5 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 0% (drug 43%) | not reported in cached trials |
| Red blood cell sedimentation rate | 128 | 673.5 532.2–852.4ROR 676.8 · calibrated p 5e-15 ✓ | 345.1 EB05 297.8 · IC025 +6.9 3/3 methods agree | Lab value / disease marker | serious n=127 · ♀ 76% (drug 43%) · 91% clinician | not reported in cached trials |
| Familial mediterranean fever | 63 | 385.5 285.3–520.9ROR 386.4 · calibrated p 2e-12 ✓ | 240.4 EB05 194.6 · IC025 +6.0 3/3 methods agree | Likely indication confounding term in indications | serious n=58 · 90% clinician | not reported in cached trials |
| Serum amyloid a protein increased | 47 | 346.7 246.1–488.5ROR 347.3 · calibrated p 9e-12 ✓ | 219.7 EB05 171.9 · IC025 +5.6 3/3 methods agree | Lab value / disease marker | serious n=47 | not reported in cached trials |
| Heart failure with preserved ejection fraction | 76 | 329.6 252.3–430.7ROR 330.6 · calibrated p 8e-12 ✓ | 220.0 EB05 181.5 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=76 · ♀ 100% (drug 43%) | not reported in cached trials |
| Central nervous system lupus | 42 | 192.7 137.6–270.0ROR 193.0 · calibrated p 1e-9 ✓ | 145.0 EB05 111.8 · IC025 +5.3 3/3 methods agree | Labeled (related wording) related wording | serious n=42 · ♀ 100% (drug 43%) | not reported in cached trials |
| Body mass index abnormal | 42 | 178.2 127.5–249.1ROR 178.5 · calibrated p 3e-9 ✓ | 136.7 EB05 105.4 · IC025 +5.2 3/3 methods agree | Lab value / disease marker | serious n=42 · ♀ 100% (drug 43%) | not reported in cached trials |
| Gouty tophus | 39 | 168.2 119.1–237.6ROR 168.5 · calibrated p 5e-9 ✓ | 130.1 EB05 99.3 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=35 | not reported in cached trials |
| Granuloma skin | 139 | 161.6 134.7–193.8ROR 162.4 · calibrated p 3e-9 ✓ | 131.9 EB05 114.5 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=139 · ♀ 78% (drug 43%) · 92% clinician | not reported in cached trials |
| Behcet's syndrome | 24 | 160.5 103.5–248.9ROR 160.7 · calibrated p 1e-8 ✓ | 120.9 EB05 85.5 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=21 | not reported in cached trials |
| Enthesopathy | 245 | 147.4 128.7–168.8ROR 148.8 · calibrated p 6e-9 ✓ | 123.2 EB05 110.8 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=245 | not reported in cached trials |
| Autoinflammatory disease | 25 | 110.2 72.6–167.5ROR 110.3 · calibrated p 2e-7 ✓ | 90.4 EB05 64.4 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=24 | not reported in cached trials |
| Type 2 lepra reaction | 22 | 105.9 67.9–165.2ROR 106.0 · calibrated p 3e-7 ✓ | 86.7 EB05 60.3 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=22 · ♀ 0% (drug 43%) · 100% clinician | not reported in cached trials |
| Blood parathyroid hormone decreased | 157 | 94.2 79.9–111.1ROR 94.8 · calibrated p 2e-7 ✓ | 83.5 EB05 73.1 · IC025 +5.8 3/3 methods agree | Lab value / disease marker | serious n=157 · ♀ 81% (drug 43%) · 91% clinician | not reported in cached trials |
| Serositis | 52 | 83.4 62.7–111.0ROR 83.6 · calibrated p 7e-7 ✓ | 73.6 EB05 58.3 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=52 · ♀ 100% (drug 43%) | not reported in cached trials |
| Tenosynovitis | 254 | 81.0 71.2–92.1ROR 81.8 · calibrated p 5e-7 ✓ | 73.2 EB05 65.9 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=254 | not reported in cached trials |
| Panniculitis | 188 | 67.7 58.4–78.5ROR 68.2 · calibrated p 2e-6 ✓ | 62.1 EB05 55.0 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=188 · ♀ 81% (drug 43%) | not reported in cached trials |
| Myopathy toxic | 46 | 66.9 49.5–90.3ROR 67.0 · calibrated p 3e-6 ✓ | 60.3 EB05 47.0 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious n=46 · ♀ 21% (drug 43%) · 100% clinician | not reported in cached trials |
| Neuromyopathy | 78 | 63.3 50.3–79.7ROR 63.5 · calibrated p 4e-6 ✓ | 57.9 EB05 47.9 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=77 · 100% clinician | not reported in cached trials |
| Gouty arthritis | 54 | 58.2 44.2–76.7ROR 58.3 · calibrated p 7e-6 ✓ | 53.3 EB05 42.4 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=52 · ♀ 22% (drug 43%) | not reported in cached trials |
| Alanine aminotransferase abnormal | 140 | 57.2 48.2–67.9ROR 57.5 · calibrated p 6e-6 ✓ | 53.1 EB05 46.1 · IC025 +5.2 3/3 methods agree | Lab value / disease marker | serious n=140 | not reported in cached trials |
| Gout | 1,122 | 53.3 50.3–56.6ROR 55.7 · calibrated p 7e-6 ✓ | 50.0 EB05 47.6 · IC025 +5.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 39.1 | not reported in cached trials |
| Rheumatoid nodule | 163 | 49.8 42.5–58.3ROR 50.1 · calibrated p 1e-5 ✓ | 46.6 EB05 40.9 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=163 · ♀ 82% (drug 43%) | not reported in cached trials |
| Pleuropericarditis | 22 | 46.3 30.1–71.2ROR 46.3 · calibrated p 5e-5 ✓ | 42.3 EB05 29.5 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=22 | not reported in cached trials |
| Urticarial vasculitis | 28 | 45.6 31.1–66.7ROR 45.6 · calibrated p 4e-5 ✓ | 42.0 EB05 30.5 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=28 · ♀ 100% (drug 43%) · 100% clinician | not reported in cached trials |
| Episcleritis | 35 | 42.9 30.5–60.3ROR 43.0 · calibrated p 6e-5 ✓ | 39.9 EB05 30.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=35 · ♀ 100% (drug 43%) | not reported in cached trials |
| Pericarditis constrictive | 21 | 42.7 27.5–66.3ROR 42.8 · calibrated p 8e-5 ✓ | 39.3 EB05 27.1 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=20 · 100% clinician | not reported in cached trials |
| Rheumatoid lung | 46 | 40.1 29.8–53.9ROR 40.2 · calibrated p 7e-5 ✓ | 37.7 EB05 29.4 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=46 · ♀ 74% (drug 43%) | not reported in cached trials |
| Myopericarditis | 34 | 40.1 28.4–56.5ROR 40.1 · calibrated p 8e-5 ✓ | 37.4 EB05 28.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=34 · 100% clinician | not reported in cached trials |
| Chondrocalcinosis | 30 | 40.0 27.7–57.7ROR 40.0 · calibrated p 9e-5 ✓ | 37.3 EB05 27.4 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=29 | not reported in cached trials |
| Muscle abscess | 26 | 34.8 23.5–51.6ROR 34.9 · calibrated p 2e-4 ✓ | 32.7 EB05 23.4 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 0% (drug 43%) | not reported in cached trials |
| C-reactive protein abnormal | 262 | 34.1 30.2–38.6ROR 34.4 · calibrated p 1e-4 ✓ | 32.7 EB05 29.5 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious n=260 | not reported in cached trials |
| Defaecation disorder | 27 | 33.8 23.0–49.7ROR 33.9 · calibrated p 2e-4 ✓ | 31.8 EB05 23.0 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=27 · ♀ 100% (drug 43%) · 100% clinician | not reported in cached trials |
| Chronic kidney disease-mineral and bone disorder | 41 | 31.7 23.2–43.3ROR 31.7 · calibrated p 3e-4 ✓ | 30.1 EB05 23.2 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=41 · ♀ 22% (drug 43%) | not reported in cached trials |
| Hyperparathyroidism secondary | 86 | 28.1 22.7–34.9ROR 28.2 · calibrated p 4e-4 ✓ | 27.1 EB05 22.6 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=85 | not reported in cached trials |
| Drug tolerance decreased | 94 | 27.8 22.6–34.1ROR 27.9 · calibrated p 4e-4 ✓ | 26.7 EB05 22.5 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious n=89 · ♀ 84% (drug 43%) | not reported in cached trials |
| Chondrocalcinosis pyrophosphate | 26 | 27.5 18.6–40.6ROR 27.5 · calibrated p 7e-4 ✓ | 26.1 EB05 18.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=23 | not reported in cached trials |
| Hypersensitivity vasculitis | 84 | 26.1 21.0–32.5ROR 26.2 · calibrated p 6e-4 ✓ | 25.2 EB05 21.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=84 · ♀ 87% (drug 43%) | not reported in cached trials |
| Skin necrosis | 164 | 26.0 22.3–30.4ROR 26.2 · calibrated p 6e-4 ✓ | 25.2 EB05 22.1 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=164 · ♀ 80% (drug 43%) · 91% clinician | not reported in cached trials |
| Tongue disorder | 229 | 26.0 22.8–29.6ROR 26.2 · calibrated p 6e-4 ✓ | 25.1 EB05 22.5 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=227 | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Colchicine as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).
- NCT02551094 — Colchicine Cardiovascular Outcomes Trial (COLCOT) (N=4745, PHASE3; 14 AE terms posted; arms: Colchicine Placebo; Colchicine)
- NCT04322682 — Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (N=4506, PHASE3; 67 AE terms posted; arms: Colchicine; Placebo)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Diarrhoea (diarrhea) | 2,397 | 3.0 2.9–3.1ROR 3.2 · calibrated p 0.567 | 3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 | NCT02551094: 225/2,330 (9.7%) on Colchicine; 208/2,346 (8.9%) control |
| Off label use (used outside approved label) | 2,204 | 2.0 2.0–2.1ROR 2.1 · calibrated p 0.986 | 2.0 EB05 2.0 · IC025 +1.0 | Reporting / coding artifact | serious PRR 2.3 | not reported in cached trials |
| Drug ineffective (drug did not work) | 2,021 | 1.2 1.2–1.3ROR 1.2 · calibrated p 0.473 | 1.2 EB05 1.2 · IC025 +0.2 | Reporting / coding artifact | serious PRR 2.0 | not reported in cached trials |
| Nausea | 1,792 | 1.8 1.7–1.9ROR 1.9 · calibrated p 0.877 | 1.8 EB05 1.7 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.1 | NCT04322682: 43/2,195 (2.0%) on Colchicine; 47/2,217 (2.1%) control |
| Fatigue (tiredness) | 1,629 | 1.7 1.6–1.8ROR 1.7 · calibrated p 0.785 | 1.7 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.8 | not reported in cached trials |
| Arthralgia (joint pain) | 1,355 | 2.6 2.5–2.8ROR 2.7 · calibrated p 0.727 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 1,350 | 1.9 1.8–2.0ROR 2.0 · calibrated p 0.924 | 1.9 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 1.7 | NCT04322682: 5/2,195 (0.2%) on Colchicine; 4/2,217 (0.2%) control (serious AE) |
| Acute kidney injury (sudden kidney damage) | 1,300 | 6.9 6.5–7.3ROR 7.2 · calibrated p 0.091 | 6.8 EB05 6.5 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · 92% clinician | NCT04322682: 1/2,195 (0.0%) on Colchicine; 1/2,217 (0.0%) control (serious AE) |
| Headache | 1,263 | 1.6 1.5–1.7ROR 1.6 · calibrated p 0.737 | 1.6 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.9 · ♀ 63% (drug 43%) | NCT04322682: 3/2,217 (0.1%) control (serious AE) |
| Vomiting | 1,225 | 2.1 2.0–2.2ROR 2.1 · calibrated p 0.977 | 2.1 EB05 2.0 · IC025 +1.0 | Labeled adverse reaction exact term | serious PRR 2.0 | NCT04322682: 6/2,195 (0.3%) on Colchicine; 4/2,217 (0.2%) control |
| Toxicity to various agents | 1,214 | 5.8 5.5–6.2ROR 6.1 · calibrated p 0.146 | 5.8 EB05 5.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 · 96% clinician | not reported in cached trials |
| Pain | 1,146 | 1.5 1.4–1.6ROR 1.5 · calibrated p 0.652 | 1.5 EB05 1.4 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.4 | NCT04322682: 1/2,195 (0.0%) on Colchicine; 1/2,217 (0.0%) control (serious AE) |
| Gout | 1,122 | 53.3 50.3–56.6ROR 55.7 · calibrated p 7e-6 ✓ | 50.0 EB05 47.6 · IC025 +5.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 39.1 | not reported in cached trials |
| Drug interaction | 1,105 | 5.6 5.3–5.9ROR 5.8 · calibrated p 0.163 | 5.6 EB05 5.3 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 4.3 · 93% clinician | not reported in cached trials |
| Rash | 980 | 1.8 1.7–1.9ROR 1.8 · calibrated p 0.856 | 1.8 EB05 1.7 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.4 · ♀ 63% (drug 43%) | not reported in cached trials |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- X-linked lymphoproliferative syndrome — n=24, PRR 2,104.8
- Heart failure with preserved ejection fraction — n=76, PRR 329.6
- Gouty tophus — n=39, PRR 168.2
- Granuloma skin — n=139, PRR 161.6
- Behcet's syndrome — n=24, PRR 160.5
- Enthesopathy — n=245, PRR 147.4
- Autoinflammatory disease — n=25, PRR 110.2
- Type 2 lepra reaction — n=22, PRR 105.9
- Serositis — n=52, PRR 83.4
- Tenosynovitis — n=254, PRR 81.0
✓ A hand-written Bradford Hill causality assessment exists for this drug: Colchicine ↔ Myopathy.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Colchicine?
In FDA FAERS, the most frequently co-reported reaction terms for Colchicine are diarrhoea, nausea, fatigue, arthralgia, dyspnoea, acute kidney injury. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Colchicine have an FDA boxed warning?
No. The FDA label retrieved for Colchicine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Colchicine causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 0f69b9c6-8c00-45e2-b950-34dc5ae62352, effective 20250701; matched on
openfda.generic_name.exact:"COLCHICINE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,215 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
COLCHICINE, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.